BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER

    K Number: K000438 · Decision May 3, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    4
    Review Days
    83

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    Basic Information

    Device Name
    MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER
    K Number
    K000438
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biosurgical Corp.
    Date Received
    February 10, 2000
    Decision Date
    May 3, 2000
    Product Code
    FMF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMF Syringe, Piston

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    Other Clearances by Biosurgical Corp.

    K Number Device Name
    K000048 SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1
    K992351 SEALOUETTE FIBRIN SEALANT APPLICATOR
    K964597 BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE